This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis.
Chronic kidney disease is a common disease that affects health seriously. In some regions of China, the morbidity of this kind of disease is as high as 10.8%. Primary glomerulopathy is one of the pathogenesis of chronic kidney disease, which occupied 50%-60%. However, at present, there is still a lack of effective means for the treatment of primary glomerulonephritis in CKD stage 3. Huaiqihuang Granule is a kind of Chinese herbal medicine compound preparation, Previous researches showed that Huaiqihuang has a comprehensive effect on primary glomerulonephritis. In this study, there were about 40 first-class hospitals participating in. We planned to enroll 466 participants, who will be randomly divided into the Huaiqihuang Granule group (experimental group) and the Valsartan group (control group). All participants will take medication for 48 weeks, and investigators will follow up participates at weeks 0, 8,16, 24, 32, 40, 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
466
Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.
Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
Time frame: 48 weeks
Change in serum creatinine levels from baseline
Serum creatinine is being assessed once every 8 weeks for a total of 6 times during the whole study
Time frame: Start of treatment until the end of the treatment for 48 weeks
Change in 24-hour urine protein ration from baseline.
Urinary protein is being assessed once every 8 weeks for a total of 6 times during the whole study
Time frame: Start of treatment until the end of the treatment for 48 weeks
Changes in urine erythrocyte levels from baseline
Urine erythrocyte is being assessed once every 8 weeks for a total of 6 times during the whole study
Time frame: Start of treatment until the end of the treatment for 48 weeks
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